March 23, 2010 - See Notice NOT-OD-10-069 This notice terminates the Institutional Research Training and Institutional Research Career Development Programs listed below because they provide application instructions for paper submissions using the PHS 398 forms.

Purpose. The purpose of the Neurological Academic Development
Award (K12) is to facilitate and support the career development of
pediatric neurologists who have made a commitment to independent research
careers.

Mechanism of Support. This Funding Opportunity Announcement (FOA) will
utilize the Mentored Clinical Scientist Development Institutional Program
Award (K12) mechanism. The NINDS K12 program provides support for up to
three years of supervised study and research for clinically trained
professionals who have the potential to develop into productive, clinical
investigators.

Funds Available and Anticipated Number of Awards. The total amount awarded and the number of awards will
depend upon the funds available and the quality, duration, and costs of
the applications received.

Budget and Project Period. Awards in response to this program announcement will be
for a total project period up to five years.

Eligible Project Directors/Principal
Investigators (PDs/PIs). Eligible PDs/PIs include
established clinical-researchers with acknowledged accomplishments in
research training, scientific expertise, leadership, and administrative
skills. In addition, eligible PDs/PIs should have a superior record of
preparing clinicians for careers as independent researchers.

Number of PDs/PIs. Only one
PD/PI may be designated on this K12 program. Multiple PDs/PIs provisions
do not apply to this FOA.

Eligible Scholar Candidates. Scholar
candidates selected for support as scholars in the K12 program must be
U.S. citizens or non-citizen nationals, or individuals lawfully admitted
for permanent residence, who hold a medical degree, are licensed to
practice medicine in the USA and have been trained in pediatric neurology,
and can commit a minimum of 75% of full-time professional effort
conducting research, career development, and/or research related
activities.

Resubmissions. Up to two resubmissions of an application will be
accepted.

The Neurological Sciences Academic Development Award (NSADA)
(K12) is an award to an educational institution or professional organization to
facilitate and support career development experiences for pediatric neurologists
leading to research independence. This is a continuation of the original NSADA
program, which was initiated by NINDS in October 1992. Under this award, newly
trained pediatric neurologists are to be selected and appointed to this program
by the grantee institution. It is expected that individuals appointed to the
NSADA program will subsequently apply for their own Mentored Clinical Scientist
Development Award (K08), the Mentored Patient-Oriented Career Development Award
(K23), an NINDS Research Scientist Development Award (K02) or an R01, to
continue their research training (see "Research Objectives").

The program should be designed to accommodate research
Scholars with varying levels of experiences. For example, a prospective
research candidate with limited experience in a given field of research may
find it appropriate to engage in a structured, phased developmental program,
including a designated period of didactic training followed by a period of
supervised research experience. The entire program should be comparable in
scope and rigor to meeting the requirements for an advanced research degree.
Each candidate supported under this award should propose a research plan that
has: (1) intrinsic research importance, (2) will serve as a suitable vehicle
for learning the methodology, theories, and concepts needed for a well-trained
independent clinician-researcher, and (3) will provide data and/or publications
that will be useful in the submission of subsequent individual research
applications. The application should include a description of one or more
proposed Scholar candidates and the research plan proposed for that specific
Scholar.

Research Career Objectives

The applicant organization must have a well-established
research and clinical career development program and qualified faculty to serve
as mentors. The research candidate, mentor, and institution must develop
innovative programs to maximize the available research and educational
resources. The NSADA program will support up to three research Scholars for up
to a maximum of three years consisting of consecutive 12-month appointments
(non-consecutive appointments are possible on a case-by-case basis with written
approval of the NINDS program staff listed as the contact for this FOA). The
candidate will acquire knowledge and research skills in scientific areas
relevant to his/her career development goals. This should include relevant
didactic and laboratory experiences that are consistent with the research
candidate's prior experience and needs.

The NSADA program award provides 5 years of potentially
renewable support. The subsequent continuation of the NSADA program will in
part depend on the progress made by Scholars, both in terms of obtaining their
own individual NIH Career Development awards, and/or R01 or equivalent grants.
The NINDS considers an R01-equivalent grant to be an independent,
peer-reviewed, multi-year award with the awardee as PI, with a total award of
at least $150,000 per year for 3 years or $200,000 per year for 2 years.
Applications from institutions with previous K-12 awards must contain a
progress report documenting the accomplishments and current career activities
of former Scholars.

Program Components

1. Project Director/Principal Investigator (PD/PI)

The proposed PD/PI should possess the scientific expertise,
leadership and administrative capabilities required to coordinate and supervise
an interdisciplinary research and development program. The Director should be
experienced in the design and management of programs for developing
investigators, and should be able to demonstrate a superior record of
preparation of clinicians for independent research. In addition, applicants
are encouraged to form a committee with representatives from appropriate basic
and/or clinical science departments to advise the PD/PI on management of the
program. (For a detailed description, see Section III.1B.)

2. Mentors

Each research candidate appointed in the program award must
have a primary mentor who: (1) is recognized as an accomplished investigator,
(2) is actively involved in basic or clinical research, and (3) has a
successful record of providing the type of career development activities
required under this award. An assigned mentor will provide guidance for the
development of each research candidate assigned to the program. The mentor
must be committed to continue this involvement throughout the candidate's total
period of development under the award. (For a detailed description, see Section
III.1B.). Because a critically important aspect of the training should include
mentoring in grant writing, and because Scholars are expected to apply for NIH
career awards to continue their research after completion of the NSADA career
development activity, the mentor should also have a strong track record in
obtaining NIH funding for research. If a primary mentor’s research funds come
predominantly from outside the NIH system, Scholars should have a co-mentor
with a strong history of NIH funding.

3. Scholar Candidates

The NINDS expects Scholars candidates appointed to the NSADA
program to have demonstrated potential to develop into successful researchers.
At least 9 person months (equivalent to 75%) of the candidate's full-time
professional effort must be devoted to the program and the remainder devoted to
developing other clinical and teaching pursuits consonant with the objectives
of the award. The NSADA may support up to a maximum of 3 years of research
career development activities. (For a detailed description, see Section III.1B.)

4. Advisory Committee

An advisory committee for each scholar should be
established. It may be a single committee for the program or tailored to the
needs of each individual scholar, and should be composed of experts in all
areas necessary to insure the success of the scholar(s) in research, career
development and ultimately the creation and management of an independent
research lab.

5. Evaluation and Tracking

A process for evaluation and tracking of each scholar’s
progress must be established and should be described. Programs are encouraged
to track applicants after they have left the program and obtain information
from program graduates that could be used to improve the program.

7. Recruitment Plan

The application should describe a recruitment plan designed
to obtain the best possible scholars into the program.

8. Research Environment/Institutional Commitment

Beyond the research activities described in the research
plan, the institution must describe what current and future resources are or
will be used to encourage research by junior faculty and facilitate development
of their research careers. It should document what equipment, facilities and
resources will be made available to the Scholar candidates (see Resource Format
Page in PHS 398). In addition, for the candidate identified in the
application, and for future appointments to the K12 program, the institution
must submit the institutional commitment agreement to support the candidate as
described in the PHS 398 form, with signatures as described in that section.
For the candidate named in the application, the form must be included with the
application. It is not part of the 25-page limit for the Research Plan
components.

Section
II. Award Information

1. Mechanism of Support

This FOA will
use theNIH Mentored Clinical Scientist
Development Program Award or K12 award mechanism. As the applicant institution,
you will be solely responsible for the planning, direction, and execution of
the proposed program. The program provides up to 5 years of support and is
renewable based on a successful competing renewal application, programmatic
needs and the availability of funds.

This
FOA uses just-in-time concepts. It also uses the non-modular budget formats
(described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the “Initial Budget Period” and the “Entire
Proposed Period of Support” is to be submitted with the application.

2. Funds Available

Because the nature and scope of the proposed research will
vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of NINDS
provide support for this program, awards pursuant to this funding opportunity
are contingent upon the availability of funds and the receipt of a sufficient
number of meritorious applications. Applications submitted in response to this
K12 FOA will compete for available funds with all other NINDS recommended
applications.

Allowable Costs

Allowable costs must be consistent with NIH policy and be
reasonable, allocable, well documented and fully justified for the program
proposed in the application. Grant funds may not be used to supplant funds
otherwise available at the applicant institution.

1. Candidates/Scholars

The maximum allowable salary per Scholar is $85,000 per
year, and the maximum allowable research costs are $30,000 per year. The total
salary requested for each research candidate must be based on a full-time,
12-month staff appointment. It must be consistent both with the established
salary structure at the institution and with salaries actually provided by the
institution from its own funds to other staff members of equivalent
qualifications, rank, and responsibilities in the department concerned. If
full-time, 12-month salaries are not currently paid to comparable staff
members, the salary proposed must be appropriately related to the existing
salary structure.

Research funds may be used for: (a) tuition, fees, and
books related to career development; tuition fees are not to exceed $12,000
total per candidate over the entire funding period (b) research expenses, such
as supplies, equipment and technical personnel; (c) travel to research meetings
or training; and (d) statistical services including personnel and computer
time.

2. Facilities and Administrative (F&A)
Costs

These costs, which were formerly called indirect costs,
will be reimbursed at eight percent of modified total direct costs or at the
actual F&A cost rate, whichever is less.

Under this FOA, the K12 grant is not subject to the
Streamlined Non-competing Application Process (SNAP). In general this means
that all reporting of budgetary information and program progress are provided
in greater detail in an annual progress report. While the K12 is subject to
Expanded Authorities, the one exception to this is that carryover of funds from
one fiscal year to the next must be approved by the NINDS Program and Grants
Administration staff (see INQUIRIES).

The applicant institution or organization must have
adequate numbers of highly trained faculty in clinical and basic sciences with
interest and capability to provide guidance to clinically trained individuals
in the development of research independence.

1.
B. Eligible Individuals

Project Director/Principal Investigator (PD/PI)

Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed institutional academic career program is invited to work with his/her
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support. The proposed PD/PI should possess the
scientific expertise, leadership and administrative capabilities required to
coordinate and supervise an interdisciplinary research and development
program. The Director should be experienced in the design and management of
programs for developing investigators, and should be able to demonstrate a
superior record of preparation of clinicians for independent research. In
addition, applicants are encouraged to form a committee with representatives
from appropriate basic and/or clinical science departments to advise the PD/PI
on management of the program.

Applicants may submit a resubmission application, but such
application must include an Introduction addressing the previous peer review
critique (Summary Statement).

Applicants may submit a renewal application.

Mentors

Each research Scholar candidate appointed in the program
award must have a primary mentor who: (1) is recognized as an accomplished
investigator, (2) is actively involved in basic or clinical research, and (3)
has a successful record of providing the type of training required under this
award. An assigned mentor will provide guidance for the development of each
research candidate assigned to the program. The mentor must be committed to
continue this involvement throughout the candidate's total period of
development under the award.

Scholar Candidates

The NINDS expects Scholars appointed to the NSADA program
to have demonstrated potential to develop into successful researchers. At
least 9 person months (equivalent to 75%) of the candidate's full-time
professional effort must be devoted to the program and the remainder devoted to
developing other clinical and teaching pursuits consonant with the objectives
of the award. The NSADA may support up to a maximum of 3 years of research
career development activities for each Scholar.

Institutions with a NSADA should recruit and select Scholar
candidates rather than submitting a separate application on behalf of each
prospective research candidate. This FOA is intended to provide support for the
development of clinician-scientists in the same manner and under the same
conditions as the individual Mentored Clinical Scientist Development Award
(K08) and the Mentored Patient-Oriented Research Career Development Award
(K23). Therefore, Scholar candidates for support under this FOA must have the
following: (1) a clinical degree or its equivalent, (2) residency training (or
its equivalent), (3) a license to practice medicine in the U.S.A., (4) a
mentor(s) who has extensive and well-funded research experience and a
successful track record of training clinician-scientists to in child neurology,
and (5) willingness to spend a minimum of 9 person-months (equivalent to 75%)
of full-time professional effort conducting research, career development,
and/or research related activities.

Research Scholar candidates appointed under this program
award must be U.S. citizens or non-citizen nationals, or have been lawfully
admitted for permanent residence and possess an Alien Registration Receipt Card
(I-151 or I-551) or some other verification of legal admission as a permanent
resident. Non-citizen nationals, although not U.S. citizens, owe permanent
allegiance to the U.S. They are usually born in lands that are not states, but
are under U.S. sovereignty, jurisdiction, or administration. Individuals on
temporary or student visas are not eligible.

Research candidates, who are or have been former principal
investigators on NIH individual mentored or non-mentored career awards (e.g.
K01, K02, K08, K22, K23), major research project awards (e.g. R01),
sub-projects of program project (P01) or center grants (P50), or the
equivalent, are not eligible for appointment under this program. Exceptions
may be made for individuals who are reentering the research field after an
extended absence or are making a significant shift in their research focus that
requires that they have additional training. Scholar candidates who were
former or who are current principal investigators on NIH small grants (R03) or
exploratory/developmental grants (R21) remain eligible. Research Scholar
candidates may not concurrently hold any other PHS award that duplicates the
provisions of this award.

Institutional Eligibility and Commitment

The applicant institution must be the primary site for the
Institutional Career Development program and should demonstrate a commitment to
the Program’s goals, submitting with the application documentation of faculty,
facilities and other resources that will be available on site to the program.

Award Termination

The Director of the NIH may discontinue an award upon determination
that the purpose or terms of the award are not being fulfilled. In the event
an award is terminated, the Director of the NIH will notify the grantee
institution and career award recipient in writing of this determination, the
reasons therefore, the effective date, and the right of the program director to
appeal the decision.

Applications must be prepared
using the most current PHS 398 research grant application instructions and
forms. Applications must have a D&B Data Universal Numbering System (DUNS)
number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.

The title
and number of this funding opportunity must be typed in item (box) 2 only of
the face page of the application form and the YES box must be checked.

Applications
must be prepared using the research grant application forms found in the PHS
398 instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three signed photocopies in one
package to:

Upon receipt applications will be evaluated for completeness by CSR.
Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding
opportunity that is essentially the same as one currently pending initial merit
review unless the applicant withdraws the pending application. The NIH will not
accept any application that is essentially the same as one already reviewed. The NIH will accept a
resubmission application, but such application must include an Introduction
addressing the critique from the previous review.

All NIH awards are subject to the terms and conditions, cost principles,
and other considerations described in the NIH Grants Policy Statement. The
Grants Policy Statement can be found at (http://grants.nih.gov/grants/policy/policy.htm).

Pre-award costs are allowable. A grantee may, at its own risk and
without NIH prior approval, incur obligations and expenditures to cover costs
up to 90 days before the beginning date of the initial budget period of a new or renewalaward if such costs: 1) are
necessary to conduct the project, and 2) would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or
non-competing award imposes no obligation on NIH either to make the award or to
increase the amount of the approved budget if an award is made for less than
the amount anticipated and is inadequate to cover the pre-award costs incurred.
NIH expects the grantee to be fully aware that pre-award costs result in
borrowing against future support and that such borrowing must not impair the
grantee's ability to accomplish the project objectives in the approved time
frame or in any way adversely affect the conduct of the project. See NIH
Grants Policy Statementhttp://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

NINDS support beyond the initial five-year project period
is not guaranteed and is dependent upon the availability of appropriated funds
and success in any competition for renewed support. In the event that there is
no further support, no phase-out funds will be provided. Thus, the applicant
institution must have plans in place to provide continued support to remaining
scholars in the event that funding from the NINDS is not available.

6. Other Submission Requirements and Information

The instructions in the Form PHS 398 do not fully apply to
the special needs of this grant application. Therefore, please follow the
modified instructions below in preparing an application for a Neurological
Sciences Academic Development Award (NSADA) (K12). The application should be
organized as per PHS 398 with specific additional information as detailed below
(if questions arise when following this format, applicants should refer
regularly to those sections of this announcement that delineate “Other-Special
Eligibility Criteria”).

1. Career Development Program

The application should describe the overall theme of the
program, the particular career development activities planned for Scholar
candidates and the expected outcomes for candidates. It should document the
experience of the PD/PI and other faculty as mentors including information on
the career outcomes of former Scholars. It should include a clear commitment of
staff time. Particular developmental activities mentioned such as seminars,
scientific meetings, training in responsible conduct of research, and
presentations should be linked to the overall theme and goals of the program.
This section should identify explicitly the advantages to this site of a
program-based career development award as opposed to, or in addition to,
creating environments supportive of individual efforts by junior faculty to
obtain career development and similar awards.

The application should indicate what other teaching and/or
clinical responsibilities, if any, are expected of the Scholar candidates and
the extent to which these activities complement or enrich the research and
research development experiences proposed in the award.

2. Research Activities

Applicants should describe the funded research activities
of the mentoring team. The description should include an account of how the
ongoing research offers opportunities for Scholar candidates to develop
research ideas and strategies and offers ways for them to combine methods or
concepts from different funded projects that will further their own research
careers. The research plan should show how the ongoing research exemplifies
the organizing theme of the program and offers Scholar candidates ways to
establish research consonant with that theme.

The research plan should detail how individual candidates'
research experiences will be/have been solicited and evaluated prior to
initiation. If an outside advisory committee is used to select projects,
applications should not name advisors in the application but describe how they
will be chosen.

Applications should describe the qualifications and
research plans for at least one candidate. The individual description should
each be no more than three pages and should include: (1) a Statement of
Hypothesis and Specific Aims, (2) Background, Significance and Rationale, and
(3) Research Design and Methods. No preliminary data or results are expected
in these descriptions. Literature citations may be included in a single
section covering all citations in the application and are not a part of the
three-page limit. Supporting material (not part of the three-page limit)
should include a description of how the individual plans relate both to the K12
program and to the career objectives of the candidate, and should describe the
particular mentors and mentoring resources that will be assigned to the
candidate during this project. A similar report for subsequent Scholar
candidates once the grant has been awarded will be administratively reviewed by
NINDS.

3. Advisory Committee

Applications must contain a description of the Advisory
Committee, and contain an explanation for the choice of members.

4. Institutional Commitment

Applications must contain a description of institutional
commitment to the program and to the candidates, or will be considered
incomplete and will not be reviewed. Applications that propose short-term
rotations to other institutions must also include a statement of institutional
commitment to the program by the other institution where the short-term
rotations will take place. A Resource Format page must be included in the PHS
398 application for each proposed short-term rotation site.

5. Training in the Responsible Conduct of
Research

Applications must include a description of a program that
will provide formal or informal instruction in scientific integrity or the
responsible conduct of research. Applications without plans for instruction in
the responsible conduct of research will be considered incomplete and may be
returned to the applicant without review. Plans must detail the proposed
subject matter, format, frequency, and duration of instruction, and amount and
nature of senior staff participation. No award will be made if an application
lacks this component. Although the NIH does not establish specific curricula
or formal requirements, all programs may wish to explore the availability of
the following courses offered by the Intramural Research Program (IRP):
Introduction to the Principles and Practice of Clinical Research, the Clinical
Electives Program Course on Bioethics, and the Ethics Training provided by each
individual institute. For more information visit the website of the Office of
Research Integrity at http://ori.dhhs.gov/.
Applicants must follow the application instructions found on page 49 of the
PHS-398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html)
for additional guidance.

Document prior instruction in or propose plans for
instruction in the responsible conduct of research in terms of subject matter
and duration of instruction. An award cannot be made if an application lacks
this component.

6. Recruitment and Retention plan

Applications must contain a description of the recruitment
and retention plan.

7. Tracking and Evaluation plan

Applications must contain a description of the tracking and
evaluation plan.

Do
not use the Appendix to circumvent the page limitations of the Research Plan
component. An application that does not observe the required page limitations
may be delayed in the review process.

Resource Sharing
Plan(s)

NIH considers
the sharing of unique research resources developed through NIH-sponsored
research an important means to enhance the value of, and advance, research.
When resources have been developed with NIH funds and the associated research
findings published or provided to NIH, it is important that they be made
readily available for research purposes to qualified individuals within the
scientific community. If the final data/resources are
not amenable to sharing, this must be explained in Resource Sharing section of
the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(b) Sharing Model Organisms: Regardless of
the amount requested, all applications where the development of model organisms
is anticipated are expectedto include a description of a
specific plan for sharing and distributing unique model organisms and related
resources, or state appropriate reasons why such sharing is restricted or not
possible. See Sharing
Model Organisms Policy, and NIH
Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount
requested, applicants seeking funding for a genome-wide association
study are expected to provide a plan for submission of GWAS data to the
NIH-designatedGWAS data repository, or provide an appropriate explanation
why submission to the repository is not possible. A genome-wide
association study is defined as any study of genetic variation across the
entire genome that is designed to identify genetic associations with observable
traits (such as blood pressure or weight) or the presence or absence of a
disease or condition. For further information see Policy for Sharing of
Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section
V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered
in the review process.

2. Review and Selection
Process

Applications submitted for this funding opportunity will be assigned to NINDS on the basis of established PHS referral
guidelines.

Applications
that are complete and responsive to this FOA will
be evaluated for scientific and technical merit by an appropriate peer
review group convened by the NINDSand in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.

As
part of the initial merit review, all applications will:

Undergo a selection process in which only those
applications deemed to have the highest scientific merit, generally the
top half of applications under review, will be discussed and assigned a
priority score;

Receive a written critique; and

Receive a second
level of review by the National Advisory Neurological Disorders and Stroke
Council.

Applications submitted in response to this
funding opportunity will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined
by scientific peer review.

Availability of funds.

Relevance of the proposed project to program
priorities.

Although the goals of NIH-supported
research are to advance our understanding of biological systems, improve the
control of disease, and enhance health, the reviewers are reminded that the
primary purpose of this FOA is training rather than conducting research. The
scientific review group will address and consider each of the following
criteria in assigning your application's overall score, weighting them as
appropriate for each application. Your application does not need to be strong
in all categories to be judged likely to have major impact and thus deserve a
high priority score. In the written comments, reviewers will be asked to
discuss the following aspects of your application in order to judge the
likelihood that the proposed research will have a substantial impact on the
pursuit of these goals:

Significance:Does the proposed K12 program offer
research career development experiences that will ensure the development of a
strong future cadre of child neurology researchers? Are the areas of proposed
career development program important to the NINDS mission of reducing the
burden of neurological disease?

Approach:Are the planned activities
adequately developed, consistent with the theme of the program, and sufficient
to achieve the aims of the program? Are they appropriately tailored to the
experience and interests of the candidates? Competing renewal applications: Do
current and past activities demonstrate prior success in advancing the careers
of candidates?

Investigators:Is the proposed PD/PI an acknowledged
research leader/administrator with a strong track record of training successful
researchers in child neurology? Do the proposed mentors have a strong track
record in training researchers in child neurology? Is their experience in
research and prior success in training appropriate to their role? Do the
mentors have active, well-funded research programs? Is the need for particular
mentors well justified by the aims of the program? Has the mentoring team
committed sufficient time to ensure the success of the program?

Scholar Candidates:Are the recruitment and selection
processes adequate to achieve high-quality candidates? Are the accomplishments
of any named Scholar candidates and the quality of their planned research
activities appropriate to their level of experience and expected progress
during the award? Are the efforts to recruit Scholar candidates from racial or
ethnic groups underrepresented in biomedical, behavioral or clinical research
adequate? Competing continuations and supplements: Do current and past
appointments show evidence of success at recruitment and training?

Research Environment/Institutional Commitment:Do existing
facilities and resources enrich the potential of the proposed K12 award to
provide strong research mentoring and development experiences for the
candidates? Are there support letters from individuals who control access to
these resources that show their willingness to collaborate? Does the
institution state that the Scholar candidates will be provided a minimum of 9
person-months (equivalent to 75% time) for the career development experiences
and show how they will be protected from other administrative, teaching or
clinical duties?

Training Record:This criterion evaluates the past
clinical research training record of the program, the PD/PI, and the designated
mentors. If a competing renewal, what is the success of former clinical Scholar
candidates in seeking further career development and in establishing productive
scientific careers? Evidence of a productive scientific career can include a
record of successful competition for research grants, receipt of special honors
or awards, a record of publications, receipt of patents, promotion to
scientific positions, and any other measure of success consistent with the
nature and duration of the training received. What is the track record of
success of the individuals proposed as PD/PI, mentors, and Advisory Committee
members in directing clinical research training? What is the potential of those
mentors who lack a track record and are there appropriate measures proposed to
assure their success?

Applicant Recruitment, Selection and Retention:What is the
quality and size of the applicant pool? Are the recruiting procedures,
candidate selection criteria, and retention strategies appropriate and well
defined? Are the research aptitude and commitment to clinical research of
applicants prominent in recruitment and selection? Is the racial and ethnic
diversity of the applicant pool in keeping with the availability of individuals
from underrepresented groups in the relevant scientific disciplines? Are other
underrepresented groups such as individuals with disabilities and individuals
from socially, culturally, economically, or educationally disadvantaged
backgrounds appropriately represented in the applicant pool? If this is a
competing continuation, is the past record of retention of past scholars
acceptable and does the placement and achievements of previous Scholars
demonstrate a commitment to clinical research?

Evaluation and Tracking:Does the
application describe a sufficiently strong plan that meets the evaluation and
tracking objectives? If short-term rotations are being proposed, does it
appropriately include measures to evaluate the effectiveness of these
short-term rotations?

2.A.
Additional Review Criteria:

In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:

Resubmission
Applications (formerly “revised/amended” applications): Are the responses to comments from
the previous scientific review group adequate? Are the improvements in the
resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed (see the Research Plan section on Human
Subjects in the PHS 398 instructions).

Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan section on Human Subjects in the
PHS 398 instructions).

Care
and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five points described in the Vertebrate Animals
section of the Research Plan will be assessed.

Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.

2.B.
Additional Review Considerations

Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed institutional career development program may be assessed by the
reviewers. Is the percent effort listed for the PI/PD appropriate for the work
proposed? Is each budget category realistic and justified in terms of the aims,
methods, and number of proposed scholars?

Training in the Responsible Conduct of Research: Does the
proposal include a plan for every candidate to receive formal instruction in
the responsible conduct of research? Are the plans adequate to insure adequate
instruction in the following areas: conflict of interest, responsible
authorship, policies for handling misconduct, data management, data sharing,
and policies regarding the use of human subjects, tissues and other specimens?
Have sufficient discussion of the relationship and the specific
responsibilities of the institution and the Scholar candidates appointed to the
program been planned. Do plans address the subject matter of the instruction,
the format of the instruction, the degree of faculty participation, candidate
attendance, and the frequency of instruction? Have they provided an adequate
rationale for the proposed plan of instruction? If it is a competing
continuation, is there a report showing good progress in training in the
responsible conduct of research per: the type of instruction provided, topics
covered, and other relevant information, such as attendance by Scholar
candidates and faculty participation?

2.C.
Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment
on the reasonableness of the following Resource Sharing Plans, or the rationale
for not sharing the following types of resources. However, reviewers will not
factor the proposed resource sharing plan(s) into the determination of
scientific merit or priority score, unless noted otherwise in the FOA. Program
staff within the IC will be responsible for monitoring the resource sharing.

Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award
costs. See Also Section
IV.5. Funding Restrictions.

A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.

The following related administrative policies apply to NIH
Research Career (“K”) programs:

Other Income:

Awardees may retain royalties and fees for activities such
as scholarly writing, service on advisory groups, honoraria from other
institutions for lectures or seminars, fees resulting from clinical practice,
professional consultation or other comparable activities, provided these
activities remain incidental, are not required by the research and
research-related activities of this award, and provided that the retention of
such pay is consistent with the policies and practices of the grantee
institution.

All other income and fees, not included in the preceding
paragraph as retainable, may not be retained by the career award recipient.
Such fees must be assigned to the grantee institution for disposition by any of
the following methods:

The funds may be expended by
the grantee institution in accordance with the NIH policy on
supplementation of career award salaries and to provide fringe benefits in
proportion to such supplementation. Such salary supplementation and
fringe benefit payments must be within the established policies of the
grantee institution.

The funds may be used for
health-related research purposes.

The funds may be paid to
miscellaneous receipts of the U.S. Treasury. Checks should be made
payable to the Department of Health and Human Services, NIH and forwarded
to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the
payment.

Usually, funds budgeted in an NIH supported research or
research training grant for the salaries or fringe benefits of individuals, but
freed as a result of a career award, may not be rebudgeted. The awarding
component will give consideration to approval for the use of released funds
only under unusual circumstances. Any proposed retention of funds released as
a result of a career award must receive prior written approval of the NIH
awarding component.

Special Leave:

Leave to another institution, including a foreign
laboratory, may be permitted if the proposed experience is directly related to
the purpose of the award. Only local institutional approval is required if such
leave does not exceed three months. For longer periods, prior written approval
of the NIH awarding institute or center is required. Details on the process
for submission of prior approval requests can be founds in the NIHGPS (rev.
12/03), Requests for Prior Approval, at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600130.

A copy of a letter or other evidence from the institution
where the leave is to be taken must be submitted to assure that satisfactory
arrangements have been made. Support from the K12 award will continue during
such leave.

Leave without award support may not exceed 12 months. Such
leave requires the prior written approval of the NIH component institute and
will be granted only in unusual situations.

Support from other sources is permissible during the period
of leave without award support. Such leave does not reduce the total number of
months of program support for which an individual is eligible.

Under unusual and pressing circumstances, an awardee may
submit a written request to the awarding component requesting a reduction in
professional effort below 75%. Such requests will be considered on a
case-by-case basis during the award period. In no case will it be permissible
to work at less than 50% effort. The nature of the circumstances requiring
reduced effort might include medical conditions, disability, or pressing
personal or family situations such as child or elder care. Permission to
reduce the level of effort will not be approved to accommodate job
opportunities, clinical practice, or clinical training. In each situation, the
grantee institution must submit documentation supporting the need for reduced
effort along with assurance of a continuing commitment to the scientific
development of the awardee. In addition, the awardee must submit assurance of
his/her intention to return to at least 75% as soon as possible. During the
period of reduced effort, the salary and other costs supported by the award
will be reduced accordingly.

Changes of Program: Awards are made for a specific
program under the guidance and leadership of a particular PD/PI. A change in
any of these parameters requires prior approval by NINDS. A rationale must be
provided for any proposed changes in the aims of the original, peer-reviewed
program. Programmatic changes will be evaluated to ensure that the program
remains within the scope of the original, peer-reviewed application. If the
new program does not satisfy this requirement, the award will be terminated.

Change of Project Director/Principal Investigator (PD/PI): If change of
the PD/PI is necessary, support of the award is not automatic but may be
continued with prior written approval by NINDS, provided the current PD/PI or
the grantee institution has submitted a written request for the change,
countersigned by the appropriate institutional business official, to the
program contact listed on the Notice of Grant Award describing the reasons for
the change. The Biographical Sketch of the proposed PD/PI, including a complete
listing of active research grant support, must be provided. The information in
the request must establish that the specific aims of the original peer-reviewed
program will remain unchanged under the direction of the new PD/PI and that the
new PD/PI has the appropriate research and administrative expertise to lead the
intensive supervised research training and career development experiences for
clinicians leading to research independence. This request must be submitted in
writing and sufficiently in advance of the requested effective date to allow
the necessary time for review.

Transfer of Program: Neither the integrated career
development/training program nor any component of the K12 program may be
transferred from one institution to another.

Termination: When a grantee institution plans to
terminate an award, the NINDS Grants Management Specialist listed on the NoA
must be notified in writing at the earliest possible time so that appropriate
instructions can be given for termination. The Director of the NIH may
terminate an award upon determination that the purpose or terms of the award
are not being fulfilled. In the event an award is terminated, NIH shall notify
the grantee institution in writing of this determination, the reasons
therefore, the effective date, and the right to appeal the decision.

Carryover of Unobligated Balances: The carryover
of funds from one budget period to the next requires prior written approval of
NINDS. When required, such requests must include compelling justification
including the status of candidate/scholar appointments to the program.

3. Reporting

When
multiple years are involved, awardees will be required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.This K12
program is not subject to the Streamlined Non-competing Application Process
(SNAP). In general, this means that all reporting of budgetary information and
program progress are provided in greater detail in an annual progress report.

Scholar Reporting Requirements

The institution must submit a completed Statement of
Appointment (PHS Form 2271) for each Scholar appointed or reappointed to the
training grant. This Form must be completed at the beginning of the initial
appointment and annually thereafter. No funds may be provided until this
document is submitted and accepted by the funding Institute.

Evaluation and Tracking Report: The strong
evaluation plan must include a system for tracking each appointee during the
K12 award and for a period of 5 years following each appointee’s termination
from this K12 program award. Provide information collected under the evaluation
and tracking plan proposed in the initial application. Information to be
provided includes the number of Scholars in each component of the overall
program, tracking information for those who have completed the Program, and
evaluation and tracking information for the short-term research education
component, if applicable. Each candidate’s progress must be reported on
annually.

Report on Training in the Responsible Conduct of Research: Report the type
of instruction provided, topics covered, and other relevant information, such
as attendance by Scholar candidates and faculty participation.

Progress of Individual Candidates/Scholars: Provide a
brief paragraph for each selected Scholar describing the research and didactic
training experiences completed and ongoing, as well as the specific future
plans for satisfying the requirements of the program. Provide a list of
publications for each Scholar resulting from their work in the program. Provide
information on each Scholar’s progression to research independence, including
grant applications, and grant awards.

Mentors: Information should be included
describing any mentors who have left the program or any who have been added.
For new mentors, biographical sketches should be included in the application.
Also include any recommended changes to improve the program for the
continuation years.

Financial Status Report (FSR): An annual FSR
is required and must be submitted within 90 days of the end of each budget
period. Continuation support will not be provided until the required form is
submitted and reviewed.

Final Reports: A final Progress Report and
Financial Status Report are required at the end of the grant project period or
upon relinquishment of an award. Evaluation and tracking results should be
included as part of the Final Progress Report.

Evaluation: In carrying out its stewardship of
human resource-related programs, NINDS may request information essential to an
assessment of the effectiveness of this program.

Publication and Sharing of Research Results: Scholars are
encouraged to submit reports of their findings for publication to the journals
of their choice. For each publication that results from a scholar’s research,
NIH support should be acknowledged by a footnote in language similar to the
following: “This project was supported by NIH grant number ______. Its contents
are solely the responsibility of the authors and do not necessarily represent
the official views of the NIH.”

Human Embryonic Stem Cells (hESC): Only approved
hESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/
may be used for clinical research training activities. The abstract of the
application must provide the registry identifying numbers of the hESC lines to
be used.

Section VII. Agency
Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials,
including physiologic toxicity and dose-finding studies (Phase I); efficacy
studies (Phase II); efficacy, effectiveness and comparative trials (Phase III).
Monitoring should be commensurate with risk. The establishment of data and
safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants (NIH
Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing
Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their
institutions, on issues related to institutional policies and
local IRB rules, as well as local, State and Federal laws and regulations,
including the Privacy Rule. Reviewers will consider the data sharing plan
but will not factor the plan into the determination of the scientific merit or
the priority score.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Access to Research Data through the Freedom
of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide access to research data through the Freedom of Information
Act (FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this amendment.
NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups
and their sub-populations must be included in all NIH-supported clinical
research projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research. This policy results from the NIH
Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials; and updated roles and responsibilities of NIH staff and the extramural
community. The policy continues to require for all NIH-defined Phase III clinical
trials that: a) all applications or proposals and/or protocols must provide a
description of plans to conduct analyses, as appropriate, to address
differences by sex/gender and/or racial/ethnic groups, including subgroups if
applicable; and b) investigators must report annual accrual and progress in
conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.

Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e., individuals under the
age of 21) must be included in all clinical research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject
Participants:
NIH policy requires education on the protection of human subject
participants for all investigators submitting NIH applications for research
involving human subjects and individuals designated as key personnel. The
policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.

NIH Public Access Policy Requirement:In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators
must submit or have submitted for them their final, peer-reviewed manuscripts
that arise from NIH funds and are accepted for publication as of April 7, 2008
to PubMed Central (http://www.pubmedcentral.nih.gov/),
to be made publicly available no later than 12 months after publication. As of
May 27, 2008, investigators must include the PubMed Central reference number
when citing an article in NIH applications, proposals, and progress reports
that fall under the policy, and was authored or co-authored by the investigator
or arose from the investigator’s NIH award. For more information, see the
Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department of
Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable health
information, and is administered and enforced by the DHHS Office for Civil
Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant
Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.

Healthy People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
All awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.